TAXUS ARRIVE: TAXUS Peri-Approval Registry: A Multi-Center Safety Surveillance Program

NCT00569491 | Completed Phase 4

• 1 other identifier: S2021
• Study Type: interventional
• Target: 2,585
• Locations: 1 country
• Sites: 50

Brief Summary

The TAXUS ARRIVE study is a multi-center safety and surveillance study designed to to compile safety surveillance and clinical outcomes data for the TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System in routine clinical practice and to identify low frequency TAXUS related clinical events.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Rate of TAXUS stent related cardiac events at a 1-year post implant procedure as classified by the Clinical Events Committee

  1 year post-implant procedure

Secondary Outcomes (3)

• Rate of TAXUS stent related cardiac events as classified by the Clinical Events Committee

  30 days, 6 months, 2 years post-implant procedure

• Rate of target vessel related cardiac events as classified by the Clinical Events Committee

  30 days, 6 months, 1 and 2 years post-implant procedure

• Rate of other TAXUS related events

  30 days, 6 months, 1 and 2 years post-implant procedure

Interventions

TAXUS Express 2™ DEVICE

TAXUS Express™ Paclitaxel-Eluting Coronary Stent System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Appropriate Patient Criteria: * Patient is eligible to receive a Boston Scientific TAXUS Stent. Inappropriate Patients Criteria: * Known sensitivity to paclitaxel. * Known allergy to stainless steel. * Patients in whom antiplatelet and / or anticoagulant therapy is contraindicated. * Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the stent or delivery device. * Patients with unresolved vessel thrombus at the lesion site. * Patients with coronary artery reference vessel diameters \< 2.5 mm or \> 3.75 mm. * Patients with lesions located in the left main coronary artery, ostial lesions, or lesions located at a bifurcation. * Patients with diffuse disease or poor overflow distal to the identified lesions. * Patients with tortuous vessels in the region of the obstruction or proximal to the lesion. * Patients with a recent acute myocardial infarction where there is evidence of thrombus or poor flow.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (50)

Advanced Cardiac Specialists

Gilbert, Arizona, 85233, United States

Location

Cardiology Associates of NEA

Jonesboro, Arkansas, 72401, United States

Location

University of California Davis Medical Center

Sacramento, California, 95817, United States

Location

Salinas Valley Memorial Hospital

Salinas, California, 93901, United States

Location

Good Samaritan

San Jose, California, 95124, United States

Location

Little Company of Mary Hospital

Torrance, California, 90503, United States

Location

Poudre Valley Hospital

Fort Collins, Colorado, 80524, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Advanced Clinical Research Group, LLC

Juniper, Florida, 33458, United States

Location

Florida Heart Institute

Orlando, Florida, 32803, United States

Location

Tallahassee Memorial Hospital

Tallahassee, Florida, 32308, United States

Location

Georgia Heart and Vascular Center

Macon, Georgia, 31208, United States

Location

Alexian Brothers Medical Center

Elk Grove, Illinois, 60007, United States

Location

Lutheran Hospital/NIRA

Fort Wayne, Indiana, 46804, United States

Location

St Francis Hospital

Indianapolis, Indiana, 46237, United States

Location

Genesis Medical Center

Davenport, Iowa, 52803, United States

Location

Our Lady of Lourdes

Lafayette, Louisiana, 70503, United States

Location

Willis Knighton Medical Center

Shreveport, Louisiana, 71103, United States

Location

Northeast Cardiology Associates

Bangor, Maine, 04401, United States

Location

Maine Medical Center

Portland, Maine, 04102, United States

Location

Delmarva Heart Research Foundation, Inc

Salisbury, Maryland, 21804, United States

Location

Regional Cardiology Associates

Grand Blanc, Michigan, 48439, United States

Location

Metro Cardiology Consultants

Coon Rapids, Minnesota, 55433, United States

Location

Research Medical Center

Kansas City, Missouri, 64132, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Cardiovascular Consultants of Nevada

Las Vegas, Nevada, 89109, United States

Location

Morristown Memorial

Morristown, New Jersey, 07079, United States

Location

Westchester County Medical Center

Valhalla, New York, 10595, United States

Location

Asheville Cardiology Associates, PA

Asheville, North Carolina, 28803, United States

Location

Mid-Carolina Cardiology Presbyterian Hospital

Charlotte, North Carolina, 28204, United States

Location

Pitt County Memorial Hospital

Greenville, North Carolina, 27858, United States

Location

WakeMed - Wake Heart Associates

Raleigh, North Carolina, 27610, United States

Location

Aultman Hospital

Canton, Ohio, 44710, United States

Location

Cleveland Cardiovascular Research Foundation

Fairview Park, Ohio, 44126, United States

Location

Abington Memorial Hospital

Abington, Pennsylvania, 19001, United States

Location

Presbyterian University of Pennsylvania Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Greenville Hospital Systems

Greenville, South Carolina, 29605, United States

Location

Avera Heart Hospital of South Dakota

Sioux Falls, South Dakota, 57108, United States

Location

Cardiovascular Associates, PC

Kingsport, Tennessee, 37660, United States

Location

Methodist Dallas Medical Center

Dallas, Texas, 75265, United States

Location

Texas Cardiac Center

Lubbock, Texas, 79410, United States

Location

South Texas Cardiovascular Consultants

San Antonio, Texas, 78229, United States

Location

Trinity Mother Frances Hospital

Tyler, Texas, 75702, United States

Location

Clear Lake Regional Medical Center

Webster, Texas, 77598, United States

Location

LDS Hospital

Salt Lake City, Utah, 84143, United States

Location

INOVA Fairfax Hospital

Falls Church, Virginia, 22041, United States

Location

Hope Heart Institute

Bellevue, Washington, 98004, United States

Location

St. Peters Hospital

Olympia, Washington, 98506, United States

Location

St Mary's Hospital

Huntington, West Virginia, 25702, United States

Location

Care Foundation, Inc.

Wausau, Wisconsin, 54401, United States

Location

Related Publications (3)

• Brilakis ES, Lasala JM, Cox DA, Berger PB, Bowman TS, Starzyk RM, Dawkins KD. Outcomes after implantation of the TAXUS paclitaxel-eluting stent in saphenous vein graft lesions: results from the ARRIVE (TAXUS Peri-Approval Registry: A Multicenter Safety Surveillance) program. JACC Cardiovasc Interv. 2010 Jul;3(7):742-50. doi: 10.1016/j.jcin.2010.04.012.

  PMID: 20650436 DERIVED

• Lasala JM, Cox DA, Dobies D, Baran K, Bachinsky WB, Rogers EW, Breall JA, Lewis DH, Song A, Starzyk RM, Mascioli SR, Dawkins KD, Baim DS; ARRIVE 1 and ARRIVE 2 Participating Physicians. Drug-eluting stent thrombosis in routine clinical practice: two-year outcomes and predictors from the TAXUS ARRIVE registries. Circ Cardiovasc Interv. 2009 Aug;2(4):285-93. doi: 10.1161/CIRCINTERVENTIONS.109.852178.109.852178. Epub 2009 Jul 22.

  PMID: 20031730 DERIVED

• Lasala JM, Cox DA, Lewis SJ, Tadros PN, Haas RC, Schweiger MJ, Chhabra A, Untereker WJ, Starzyk RM, Mascioli SR, Dawkins KD, Baim DS. Expanded use of the TAXUS Express Stent: two-year safety insights from the 7,500 patient ARRIVE Registry programme. EuroIntervention. 2009 May;5(1):67-77. doi: 10.4244/eijv5i1a11.

  PMID: 19577985 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Eileen Rose, MS

  Boston Scientific Corporation

  STUDY DIRECTOR

• John M Lasala, MD, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• David A Cox, MD

  Lehigh Valley Physician Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 6, 2007
• First Posted: December 7, 2007
• Study Start: February 1, 2004
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: September 25, 2008

Record last verified: 2008-09

Locations

US (50)